NCT03962933

Urine-based Detection of Non-muscle Invasive Bladder

Urine-based Detection of Non-muscle Invasive Bladder Cancer Recurrence

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 196 (actual)
• Sponsor: Nessn Azawi · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%).

Detailed description

Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%). Hypothesis: The study aims at evaluating the potential clinical impact of a highly sensitive urinary marker, Uromonitor, regarding possible reduction in number of cystoscopies. We hypothesize that the use of a sensitive urinary marker regarding recurrent tumor will enable us to reduce the number of follow-up cystoscopies without risk of delaying diagnosis of recurrence and progression cystoscopies compared to flexible cystoscopy alone. We hypothesize that number of tumors missed at follow-up cystoscopy alone or urinary marker alone is identical or in favor of a sensitive urinary marker that can detect sub-visible lesions and the examinations combined identify all tumor recurrences. Moreover, we hypothesize that tumors missed at follow-up at a given time point are very small and will be identified at next follow-up without increasing the risk of progression and that regular follow-up with cystoscopy alone therefore can be replaced by follow-up with a sensitive urinary biomarker alone - where cystoscopy only is performed if the biomarker is positive.

Conditions

• Bladder Cancer

Timeline

• Start date: 2020-01-01
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2019-05-24
• Last updated: 2024-01-30

Locations

1 site across 1 country: Denmark